The Effect of Oral Iron Supplements on Hepcidin, Insulin and Glucose Metabolism in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- insulin
研究概览
简要总结
Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented.
Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •week of pregnancy 24-28
- •pre-pregnancy BMI <27.5kg/m2
- •singleton pregnancy
- •Hb > 8.0 g/dl
- •Willing to either:
- •not take any iron supplements for 14 days (however, participants will receive a similar amount of total iron during the 4 study days that they would normally receive over 14 days) OR
- •to take the multivitamin "Burgerstein Schwangerschaft and Stillzeit" supplements over the 14 days (contains 30 mg iron)
排除标准
- •iron infusion within the past 6 months
- •severely anemic Hb<8.0g/dl
- •acute or chronic disease
- •long-term medication
- •medical problems known to affect iron homeostasis
研究组 & 干预措施
High Iron Group
15 women taking 100 mg iron twice daily for 4 days (800 mg).
干预措施: 100mg iron fumarate (Dietary Supplement)
Low Iron Group
15 women taking 30 mg iron once daily for 14 days (420 mg).
干预措施: Burgerstein Schwangerschaft & Stillzeit (Dietary Supplement)
结局指标
主要结局
insulin
时间窗: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Serum hepcidin
时间窗: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
Serum iron
时间窗: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
glucose
时间窗: At day 14, 7 days after high iron supplementation and 1 day after low iron supplementation
insulin
时间窗: before OGTT, after high/low iron supplementation at day 7
insulin
时间窗: after OGTT, after high/low iron supplementation at day 7
Serum hepcidin
时间窗: before OGTT, 1 day before high/low iron supplementation
Serum hepcidin
时间窗: after OGTT, 1 day before high/low iron supplementation
Serum hepcidin
时间窗: before OGTT, after high/low iron supplementation at day 7
Serum hepcidin
时间窗: after OGTT, after high/low iron supplementation at day 7
Serum iron
时间窗: before OGTT, 1 day before high/low iron supplementation
Serum iron
时间窗: after OGTT, 1 day before high/low iron supplementation
Serum iron
时间窗: before OGTT, after high/low iron supplementation at day 7
Serum iron
时间窗: after OGTT, after high/low iron supplementation at day 7
glucose
时间窗: before OGTT, 1 day before high/low iron supplementation
glucose
时间窗: after OGTT, 1 day before high/low iron supplementation
glucose
时间窗: before OGTT, after high/low iron supplementation at day 7
glucose
时间窗: after OGTT, after high/low iron supplementation at day 7
insulin
时间窗: before OGTT, 1 day before high/low iron supplementation
insulin
时间窗: after OGTT, 1 day before high/low iron supplementation
次要结局
- alpha glycoprotein(after OGTT, after high/low iron supplementation at day 7)
- Serum ferritin(after OGTT, after high/low iron supplementation at day 7)
- c-reactive protein(after OGTT, after high/low iron supplementation at day 7)
- soluble transferrin receptor(after OGTT, after high/low iron supplementation at day 7)
- Serum ferritin(before OGTT, 1 day before high/low iron supplementation)
- Serum ferritin(after OGTT, 1 day before high/low iron supplementation)
- Serum ferritin(before OGTT, after high/low iron supplementation at day 7)
- soluble transferrin receptor(before OGTT, 1 day before high/low iron supplementation)
- soluble transferrin receptor(after OGTT, 1 day before high/low iron supplementation)
- soluble transferrin receptor(before OGTT, after high/low iron supplementation at day 7)
- c-reactive protein(before OGTT, 1 day before high/low iron supplementation)
- c-reactive protein(after OGTT, 1 day before high/low iron supplementation)
- c-reactive protein(before OGTT, after high/low iron supplementation at day 7)
- alpha glycoprotein(before OGTT, 1 day before high/low iron supplementation)
- alpha glycoprotein(after OGTT, 1 day before high/low iron supplementation)
- alpha glycoprotein(before OGTT, after high/low iron supplementation at day 7)
研究者
Isabelle Herter-Aeberli
PhD
Swiss Federal Institute of Technology